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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01583374
Registration number
NCT01583374
Ethics application status
Date submitted
20/04/2012
Date registered
24/04/2012
Date last updated
12/05/2020
Titles & IDs
Public title
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
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Scientific title
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS
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Secondary ID [1]
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2011-001555-37
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Secondary ID [2]
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CC-10004-AS-001
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Universal Trial Number (UTN)
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Trial acronym
POSTURE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondyloarthritis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Apremilast tablet 20 mg
Treatment: Drugs - Apremilast tablet 30 mg BID
Treatment: Drugs - Placebo
Experimental: Apremilast 20 mg - Apremilast 20 mg was taken orally twice a day (BID)
Experimental: Apremilast 30 mg - Apremilast 30 mg was taken orally twice a day
Placebo Comparator: Placebo - Identically matched placebo tablets were taken orally twice a day
Treatment: Drugs: Apremilast tablet 20 mg
Apremilast 20 mg was taken orally twice a day (BID)
Treatment: Drugs: Apremilast tablet 30 mg BID
Apremilast 30 mg was taken orally twice a day
Treatment: Drugs: Placebo
Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16
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Assessment method [1]
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ASAS 20 was defined as achieving an improvement from baseline of = 20% and = 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of = 20% and = 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:
Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active
Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = "no pain" and the right-hand box = "most severe pain"
Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability
Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [1]
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Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
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Assessment method [1]
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The BASFI is a composite score based on a self-administered survey of 10 questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the degree of mobility and functional ability. The survey consists of 8 questions regarding function in AS and the last 2 reflect the ability to manage everyday life. The patient marks a box with an X on a 0 to 10 unit NRS for 10 questions; the left-hand box of 0 = easy; the right-hand box = impossible. The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. The overall score is the mean of the 10 items and ranges from 0 to 10. A higher score correlates to reduced functional ability.
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [2]
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Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
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Assessment method [2]
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The BASDAI is a composite score based on a participant self-administered survey of six questions measured using a 0 to 10 unit numerical rating scale (NRS) that assessed the participants' five major symptoms of AS: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. The participant was asked to mark the box with an X on a 0 to 10 unit NRS for each of the 6 questions. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater was considered to be indicative of active AS disease.
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [3]
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Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24
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Assessment method [3]
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ASAS 20 was defined as achieving an improvement from baseline of = 20% and = 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of = 20% and = 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:
Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active
Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = "no pain" and the right-hand box = "most severe pain"
Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability
Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [4]
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Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24
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Assessment method [4]
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The ASQoL is a validated disease specific patient reported outcomes instrument to assess the impact of ankylosing spondylitis on the quality of life of individuals with emphasis on the ability of the person to fulfill his or her needs. It consisted of 18 items requesting a yes (score=1) or no (score=0) response to questions related to the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. The summary score ranges 0-18 with higher scores indicating worse quality of life.
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Timepoint [4]
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Baseline and Week 24
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Secondary outcome [5]
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Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24
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Assessment method [5]
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The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) was a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores (based on US general population with mean of 50 and standard deviation of 10) were used in analyses. Higher scores indicate a higher level of functioning. The PCS encompasses physical functioning, role-physical, and bodily pain, as well as general health and vitality. A positive change from baseline score indicates an improvement
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Timepoint [5]
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Baseline and Week 24
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Secondary outcome [6]
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Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24
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Assessment method [6]
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The BASMI-Linear was designed to assess axial status (ie, cervical, dorsal and lumbar spine, hips, and pelvic soft tissue) and to define clinically significant changes in spinal movement. Five dimensions of movement (lateral lumbar flexion, tragus to wall, forward lumbar flexion, maximal intermalleolar distance, and cervical rotation) were measured and normalized on 0 to 10 unit NRS. The average of these scores was the total BASMI score, ranging from 0-10 with higher values indicating more severe limitation in spinal mobility.
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Timepoint [6]
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Baseline and Week 24
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Secondary outcome [7]
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Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260
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Assessment method [7]
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The Modified Stoke Ankylosing Spondylitis Spine Score is a scoring method used to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine. The m-SASSS scores 0-3.
0 = No abnormality, 1 = Erosion, Sclerosis or Squaring, 2 = Syndesmophyte, 3 = Total bony Bridging at each Site. An increase in the m-SASSS indicated a worsening of AS disease.
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Timepoint [7]
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Baseline to Week 104 and 260
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Secondary outcome [8]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
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Assessment method [8]
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A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort.
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Timepoint [8]
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From Week 0 to Week 24; the median duration of exposure was 23.57 weeks for the placebo arm, 23.71 weeks for the apremilast 20 mg arm and 24.00 weeks for the apremilast 30 mg arm.
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Secondary outcome [9]
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Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
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Assessment method [9]
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A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort.
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Timepoint [9]
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Week 0 to week 260; overall mean duration of exposure to apremilast 20 mg and 30 mg BID was 160.96 weeks
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Eligibility
Key inclusion criteria
- Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain
and stiffness, which improves with exercise, but is not relieved by rest for more than
3 months prior to screening. At the completion of screening procedures, a documented
diagnosis of definite active AS, as defined by the modified New York criteria (1984)
whereby both criteria, at least 1 radiographic criterion and at least 1 clinical
criterion, must be met
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is = 4
- Total back pain is = 4
- On stable dose of AS medication (or lack of medication) prior to randomization and
through week 24
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for
AS
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/05/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/10/2018
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Sample size
Target
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Accrual to date
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Final
490
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Recruitment in Australia
Recruitment state(s)
TAS,VIC
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Recruitment hospital [1]
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Southern Clinical Research - Hobart
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Recruitment hospital [2]
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Emeritus Research - Camberwell
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Recruitment hospital [3]
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Coastal Joint Care - Maroochydore
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Recruitment hospital [4]
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Royal Perth Hospital - Perth
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Recruitment hospital [5]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment postcode(s) [1]
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7000 - Hobart
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Recruitment postcode(s) [2]
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3124 - Camberwell
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Recruitment postcode(s) [3]
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4558 - Maroochydore
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Recruitment postcode(s) [4]
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6849 - Perth
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Recruitment postcode(s) [5]
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5011 - Woodville South
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Illinois
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Pleven
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Brno
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Hostivice
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France
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Vladimir
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Poprad
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A Coruña
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Spain
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Barcelona
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Sabadell
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Santiago de Compostela
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Sweden
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Malmö
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United Kingdom
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Barnsley
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United Kingdom
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Bath
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Leeds
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Apremilast is a new, orally available, small molecule drug that specifically inhibits
phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical
study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01583374
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Trial related presentations / publications
Gladman DD, Kavanaugh A, Gomez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.
Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.
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Amgen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01583374
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